Post by SoulTrainOz on Jul 10, 2006 20:19:35 GMT -5
Maker of popular antidepressant hasn't issued warning about possible risk of homicidal ideas
An antidepressant that Andrea Yates was taking before she drowned her 5 children in 2001 has been found to possibly increase the risk of homicidal thoughts, an Austin medical watchdog group says, but Effexor's manufacturer has not warned the public.
"Homicidal ideation" was added last year to the list of the drug's rare adverse events on Effexor XR's label and on Wyeth's Web site.
The U.S. Food and Drug Administration defines rare as occurring in fewer than 1 in 1,000 people. In the United States, about 19.2 million prescriptions for Effexor were filled last year, some of which were refills.
Dr. Moira Dolan, executive director of the Medical Accountability Network, said Sunday that she discovered the label change about 2 weeks ago in the FDA's MedWatch newsletter from November. Wyeth, a drug company based in Madison, N.J., did not send letters to doctors or issue warning labels.
"People need to be warned that this is a possible side effect," said Dolan, an Austin doctor who has reviewed Yates' medical records but is not involved in the case. "Families don't know to be aware of this possible effect. As doctors, we're not going to look through 36 pages of labeling."
Effexor is Wyeth's top-selling drug; it had $3.46 billion in worldwide sales last year, more than double what the company's No. 2 product brought in. Effexor generated 18 percent of Wyeth's total revenue last year.
"We believe there is no causal link between Effexor and homicidality," Wyeth spokeswoman Gwen Fisher said. "In our minds, we've taken every precaution."
She said that as Effexor was being studied for possible use in treating panic disorder, Wyeth found that only one person in its clinical trial reported having homicidal thoughts. Fisher said she did not know the trial date.
In approving Wyeth's application to use Effexor for that disorder, Fisher said, the FDA wanted homicidal thought listed as a rare adverse event, which is defined as something not proven to be linked to the drug. That is different from an adverse reaction, she said.
Wyeth did not notify doctors or issue warning labels because it found no link between its drug and homicidal thoughts, Fisher said.
Dolan said the Web site label mentions homicidal thoughts in the middle of a paragraph on page 36. Fisher said that the placement is appropriate and that the warning about "homicidal ideation" also appears on the 1-page package insert given to all patients. In 2004, the FDA ordered that all antidepressants carry "black box" warnings saying that the drugs increase the risk of suicidal thoughts and behavior in children. That action was driven by data showing that an average of 2 to 3 percent of children who take antidepressants have increased suicidal thoughts and actions. The link is stronger with Effexor than with other antidepressants in the same class of drugs.
James O'Donnell, assistant professor of pharmacology at Rush University Medical Center in Chicago and the author of "Drug Injury: Liability, Analysis and Prevention," said it is just as important that the public be aware of the warning about homicidal thoughts.
"For something as final as homicide, that's important to know about," O'Donnell said.
Fisher said the drug is safe and effective.
Yates, who remains jailed, continues to take Effexor as well as an
anti-psychotic drug to help stabilize her mental illness, a psychiatrist testified in Yates' retrial, which started 2 weeks ago.
Yates, 42, has pleaded not guilty by reason of insanity in her 2nd murder trial. Her 2002 capital murder conviction was overturned on appeal because some erroneous testimony may have influenced jurors.
Yates has been prescribed Effexor in varying doses since shortly after her 1st suicide attempt in 1999, said Dolan, who reviewed Yates' medical records after her 1st trial at the request of her then-husband, Russell Yates. A month before the slayings, her daily dose had increased to 450 milligrams, twice the recommended maximum dose, Dolan said.
Andrea Yates' lead attorney, George Parnham, has criticized the amount of medications that Yates was prescribed before the children's deaths. He said Wyeth should have publicized information about the possible connection between Effexor and homicidal thoughts. But, he said, that will not affect Yates' case.
"Obviously this is a severely mentally ill individual who was on a
plethora of psychiatric meds," Parnham said. "There's no question mental illness killed those children."
Parnham said Yates had postpartum psychosis and drowned the children in the family bathtub while in a delusional state, which probably had been exacerbated when she was suddenly taken off Haldol, a strong anti-psychotic drug.
Yates, who is being tried in only 3 of the deaths, will be sentenced to life in prison if convicted.
Effexor sales rose only 3.3 % from 2004 to 2005 but jumped 8.8 % in the first quarter of this year, to $945 million.
(source: Austin American-Statesman)
An antidepressant that Andrea Yates was taking before she drowned her 5 children in 2001 has been found to possibly increase the risk of homicidal thoughts, an Austin medical watchdog group says, but Effexor's manufacturer has not warned the public.
"Homicidal ideation" was added last year to the list of the drug's rare adverse events on Effexor XR's label and on Wyeth's Web site.
The U.S. Food and Drug Administration defines rare as occurring in fewer than 1 in 1,000 people. In the United States, about 19.2 million prescriptions for Effexor were filled last year, some of which were refills.
Dr. Moira Dolan, executive director of the Medical Accountability Network, said Sunday that she discovered the label change about 2 weeks ago in the FDA's MedWatch newsletter from November. Wyeth, a drug company based in Madison, N.J., did not send letters to doctors or issue warning labels.
"People need to be warned that this is a possible side effect," said Dolan, an Austin doctor who has reviewed Yates' medical records but is not involved in the case. "Families don't know to be aware of this possible effect. As doctors, we're not going to look through 36 pages of labeling."
Effexor is Wyeth's top-selling drug; it had $3.46 billion in worldwide sales last year, more than double what the company's No. 2 product brought in. Effexor generated 18 percent of Wyeth's total revenue last year.
"We believe there is no causal link between Effexor and homicidality," Wyeth spokeswoman Gwen Fisher said. "In our minds, we've taken every precaution."
She said that as Effexor was being studied for possible use in treating panic disorder, Wyeth found that only one person in its clinical trial reported having homicidal thoughts. Fisher said she did not know the trial date.
In approving Wyeth's application to use Effexor for that disorder, Fisher said, the FDA wanted homicidal thought listed as a rare adverse event, which is defined as something not proven to be linked to the drug. That is different from an adverse reaction, she said.
Wyeth did not notify doctors or issue warning labels because it found no link between its drug and homicidal thoughts, Fisher said.
Dolan said the Web site label mentions homicidal thoughts in the middle of a paragraph on page 36. Fisher said that the placement is appropriate and that the warning about "homicidal ideation" also appears on the 1-page package insert given to all patients. In 2004, the FDA ordered that all antidepressants carry "black box" warnings saying that the drugs increase the risk of suicidal thoughts and behavior in children. That action was driven by data showing that an average of 2 to 3 percent of children who take antidepressants have increased suicidal thoughts and actions. The link is stronger with Effexor than with other antidepressants in the same class of drugs.
James O'Donnell, assistant professor of pharmacology at Rush University Medical Center in Chicago and the author of "Drug Injury: Liability, Analysis and Prevention," said it is just as important that the public be aware of the warning about homicidal thoughts.
"For something as final as homicide, that's important to know about," O'Donnell said.
Fisher said the drug is safe and effective.
Yates, who remains jailed, continues to take Effexor as well as an
anti-psychotic drug to help stabilize her mental illness, a psychiatrist testified in Yates' retrial, which started 2 weeks ago.
Yates, 42, has pleaded not guilty by reason of insanity in her 2nd murder trial. Her 2002 capital murder conviction was overturned on appeal because some erroneous testimony may have influenced jurors.
Yates has been prescribed Effexor in varying doses since shortly after her 1st suicide attempt in 1999, said Dolan, who reviewed Yates' medical records after her 1st trial at the request of her then-husband, Russell Yates. A month before the slayings, her daily dose had increased to 450 milligrams, twice the recommended maximum dose, Dolan said.
Andrea Yates' lead attorney, George Parnham, has criticized the amount of medications that Yates was prescribed before the children's deaths. He said Wyeth should have publicized information about the possible connection between Effexor and homicidal thoughts. But, he said, that will not affect Yates' case.
"Obviously this is a severely mentally ill individual who was on a
plethora of psychiatric meds," Parnham said. "There's no question mental illness killed those children."
Parnham said Yates had postpartum psychosis and drowned the children in the family bathtub while in a delusional state, which probably had been exacerbated when she was suddenly taken off Haldol, a strong anti-psychotic drug.
Yates, who is being tried in only 3 of the deaths, will be sentenced to life in prison if convicted.
Effexor sales rose only 3.3 % from 2004 to 2005 but jumped 8.8 % in the first quarter of this year, to $945 million.
(source: Austin American-Statesman)